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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05611281
Other study ID # GenSci073-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 22, 2022
Est. completion date April 1, 2023

Study information

Verified date October 2022
Source GeneScience Pharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.


Description:

This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date April 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy adult subjects aged 18-45 years (including boundary values), male and female; - Body mass index: 19-26 kg/m2 (including boundary value), male weight =50 kg, female weight =45 kg; Exclusion Criteria: - Patients with a history of substance abuse and substance dependence; - Family history of sudden death;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication
The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Locations

Country Name City State
China Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College Chengdu Chengdu

Sponsors (1)

Lead Sponsor Collaborator
GeneScience Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary TEAEs Adverse events during treatment:Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults. Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;
Secondary PK characteristics To evaluate the pharmacokinetic (Peak Plasma Concentration (Cmax)) characteristics of GS3-007A in Chinese healthy adults after single, multiple, and single oral administration of high-fat meals. Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;
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